Single-dose ritanserin and alcohol in healthy volunteers: a placebo-controlled trial.

A double blind cross-over design trial was carried out to investigate the effect of simultaneous administration of alcohol (0.5 g/kg) and ritanserin (10 mg) on biological and behavioral functioning. Twenty healthy volunteers were selected to participate in the study. To assess the effect of treatments the following evaluations were performed: psychomotor tests, vital signs, intoxication, euphoria, and mood. In addition, ritanserin and alcohol plasma concentration were measured. Psychomotor performance and vital signs during the ritanserin session did not differ significantly from the placebo session. Similar results were obtained in regard to alcohol intoxication, euphoria, and mood, except for tiredness and alertness, which were significantly different compared to placebo. Differences in blood alcohol concentration between the ritanserin and the placebo sessions did not attain significance. Plasma ritanserin concentration was 143 ng/ml 1 h after alcohol administration and decayed to 53 ng/ml 6 h after alcohol consumption in the active treatment session. Our findings tend to indicate that ritanserin neither enhances the central nervous system depressant effect of alcohol nor produces a pharmacokinetic interaction during acute alcohol ingestion.

RCT Entities:   Population Interventions Outcomes